Jobs
>
Boston

    Manager, Clinical Study Start Up - Boston, United States - Verve Therapeutics, Inc.

    Verve Therapeutics, Inc.
    Verve Therapeutics, Inc. Boston, United States

    2 days ago

    Default job background
    Description

    Job Description

    Job DescriptionThe Company

    Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.

    The Position

    Verve is seeking a manager of clinical study start up that will support the strategy and implementation of start-up activities for clinical studies across all development programs. This position partners with cross-functional teams and CROs to provide input and guidance on all start up activities.

    Job Responsibilities
    • Lead study start up activities for assigned projects, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals
    • In partnership with clinical operations and other cross functional team members, the study start up lead will liaise with internal and external partners to distribute continuous status updates, as well as distributing weekly updates to internal and external partners
    • Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, complying with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
    • Manage IRB/EC and regulatory submission and approvals, including amendments and continuing reviews
    • Collect and QC Regulatory document Green Light Packets for site activation
    • Manage and archive central startup team tools and resources required to support startup team daily operations, communications, and records from study assignment to final handoff
    • Set up and maintain SSU documents in internal TMF
    • Maintain inspection-ready documentation
    • Assist project teams with trial progress by updating study trackers
    • Organize, attend, and actively contribute to project meetings such as internal team discussions, CRO meetings, support presentations, etc.
    • Identify and implement best practices, seeking continuous process improvements as appropriate
    • Liaise with sites, CROs, internal study team, at others, communicating clearly, effectively and in a timely fashion
    • Submit clinical documents in quality management system for management and team approval
    • Request, manage, distribute, and track study supplies (Regulatory Binders, Study Reference Manuals, Patient Diaries, consumables & ancillary supplies, etc.)
    • Strive to think ahead and be proactive concerning all responsibilities
    • Perform all activities in compliance with applicable regulations, company policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training
    • Other duties as assigned
    Qualifications
    • Bachelor's degree in a science-related field; advance degree preferred
    • 5+ years of clinical research / project management experience including clinical site, CRO, and/or sponsor experience
    • Direct experience in preparing and delivering Start-Up activities
    • Familiarity with clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
    • Experience working in a cross-functional team environment (e.g., Medical Affairs, Clinical Development, Regulatory, Quality Assurance, Data Management, Safety, Product Development, Finance)
    • Understanding of complexities of study start up
    • Strong interpersonal skill set necessary to develop, guide, and maintain internal and external collaborator relationships
    • Highly developed written and verbal communication skills, including presentation skills, ability to effectively articulate highly technical or complex concepts to audiences with differing levels of experience
    • Demonstrated ability to effectively influence and manage within a matrixed organization
    • Demonstrated ability to inspire, motivate, and mentor teams
    EEO Statement

    Verve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

    Recruitment & Staffing Agencies

    Verve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.

  • Alexion Pharmaceuticals

    Senior Manager, Study Start Up

    1 week ago

    Alexion Pharmaceuticals Boston, United States Full time

    This is what you will do: · The Study Start-up (SSU) Senior Manager has local/country responsibility for the delivery of site start up activities for assigned studies and is a member of local study team(s). The SSU Senior Manager works in close collaboration with CRAs, PMCO, Sup ...

  • Brigham & Women's Hospital(BWH)

    Research Assistant I, Cardiac Imaging Radiology

    1 week ago

    Brigham & Women's Hospital(BWH) Boston, United States

    **Research Assistant I, Cardiac Imaging Radiology** · This is Cardiac Imaging Research Assistant position starting Jun 1, 2024. · - Assist PI to coordinate research efforts for study protocols · - Recruit and evaluate potential study patients. Per protocol instruction, conducts t ...

  • Joslin Diabetes Center

    Research Assistant

    5 days ago

    Joslin Diabetes Center Boston, United States

    Overview: · The Kulkarni laboratory studies the biology and function of pancreatic islets including insulin secreting beta cells and glucagon-secreting alpha cells. The lab has recently started to work on signaling pathways that are critical for modulating beta cell biology inclu ...

  • Freeline Therapeutics

    Medical Director, Neurology

    6 days ago

    Freeline Therapeutics Boston, United States

    **Benefits**: · - Generous holiday allowance- Life assurance- Gym membership- Medical cover- Pension- Shower at work- Sport clubs- GP consults- Why Freeline? · - Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work ref ...

  • Boston Children's Hospital

    Clinical Research Assistant I

    1 week ago

    Boston Children's Hospital Boston, United States

    74629BR · - Medicine-GI/Nutrition · **Job Posting Description** · - Responsibilities span many aspects of study design and network collaboration, and may include: coordinating the collection of data and informed consent, interacting with the Institutional Review Board (IRB), assi ...

  • Massachusetts General Hospital(MGH)

    Program Director

    1 week ago

    Massachusetts General Hospital(MGH) Boston, United States

    **Program Director** · **_ · GENERAL SUMMARY/ OVERVIEW STATEMENT:_** · The Division of Infectious Diseases at Massachusetts General Hospital is at the forefront of innovative clinical trials. In 2020, recognizing the need for a dedicated infrastructure, they established the Infec ...

  • The Children's Center

    Behavior Support Assistant

    1 day ago

    The Children's Center Suffolk, United States

    **Come join our team** · **Considering opportunity in Franklin, Courtland and Suffolk.** · **The Children's Center, a non-profit agency, is dedicated to making a positive difference in the lives of young children, one family at a time. Our mission is to nurture and educate childr ...

  • Keolis Commuter Services

    Improvement Project Lead

    1 day ago

    Keolis Commuter Services Boston, United States

    At Keolis Commuter Services (KCS), we give every team member—and their ideas—a seat for the journey. We are a diverse team made up of different backgrounds, stories, and perspectives, which is our strength. If you're looking for a career with a company that invests in your future ...

  • Boston Child Study Center

    Practice Administrator

    2 days ago

    Boston Child Study Center Boston, United States

    **Job Title**:Practice Administrator · **Department/Program**:Practice Management · **Reports to**: Director of Practice Management · **Location**:Boston, MA · **Office Type**: In-Office · **Schedule**: M-TH 10AM-6PM · **Salary**: 50K · **Benefits**:Medical & Dental Insurance - B ...

  • Liberty Mutual

    Director Ii, Enterprise Data Science and Ai

    1 day ago

    Liberty Mutual Boston, United States

    **Pay Philosophy** · The typical starting salary range for this role is determined by a number of factors including skills, experience, education, certifications and location. The full salary range for this role reflects the competitive labor market value for all employees in the ...

  • RWE Offshore Wind

    Tribal Relations Manager, East Coast

    1 week ago

    RWE Offshore Wind Boston, United States

    **Tribal Relations Manager, East Coast**: · - **Location(s)**: · - Boston, MA, US · **RWE Offshore Wind Services, LLC** · **To start as soon as possible, full time, permanent · **Tribal Relations Manager · - East coast · **Job Summary** · **Areas of Responsibility** · - Establish ...

  • Harvard University

    Research Assistant I Lab

    1 week ago

    Harvard University Boston, United States

    **Position Description** · - The Yellen lab at Harvard Medical School Neurobiology is looking for a research technician. Our research is focused on understanding neuronal metabolism and how it is influenced by - and influences - neuronal activity and excitability. The lab develop ...

  • Museum of Science

    Education Fellow

    2 hours ago

    Museum of Science Boston, United States

    **Education Fellow - Bilingual English/Spanish (September September 2025)** · Museum of Science, Boston · - Innovation and creativity come from the unique perspectives of a diverse staff. We value your perspective._ · **SUMMARY STATEMENT**: · The Education Fellow - Bilingual Engi ...

  • The Predictive Index

    Product Manager, Platform

    1 day ago

    The Predictive Index Boston, United States

    **PURPOSE**: · The Predictive Index—the talent optimization leader—is an award-winning best place to work (Inc., Glassdoor, Boston Business Journal, The Boston Globe). · Our mission is "Better work, Better world," and we take great pride in PI's power to supercharge workplace rel ...

  • UG2

    Marketing Manager

    2 days ago

    UG2 Boston, United States

    UG2 is seeking an experienced Marketing Manager to support all aspects of our marketing and communications efforts and play a pivotal role in driving our brand visibility, generating leads, and nurturing relationships. · As a Marketing Manager at UG2, you will be responsible for ...

  • Northeastern University

    Open Rank Cooperative Education Faculty Coordinator

    2 days ago

    Northeastern University Boston, United States

    About the Opportunity · Northeastern University is a global leader in cooperative education and experiential learning in which students alternate between academic study and work experiences. The College of Engineering is seeking a Co-op Faculty member to work with our undergradua ...

  • Jacobs Engineering Group Inc.

    Electrical Technical Delivery Manager

    1 day ago

    Jacobs Engineering Group Inc. Boston, United States

    Our People & Places Solutions business - reinforces our drive to improve the lives of people everywhere and epitomizes the "why" of what we do - the tremendous positive impact and value our solutions bring to our communities and society as a whole. From facilities delivering life ...

  • Harvard University

    Staff Assistant Iii

    1 week ago

    Harvard University Boston, United States

    **Job Summary** · - The Harvard Center for Population and Development Studies (HCPDS) is a university-wide initiative, dedicated to interdisciplinary research focused primarily on the quantitative social science of population change, socioeconomic development, and public health. ...

  • Costello Medical

    Statistician

    1 day ago

    Costello Medical Boston, United States

    **Role Summary**: · - Responsibilities: You will be responsible for devising and performing statistical analysis plans and then communicating the methodologies and results of these to our clients in the healthcare sector · - Salary: $73,000 to $76,000 depending on qualifications ...

  • Harvard University

    Research Assistant I

    1 week ago

    Harvard University Boston, United States

    **Position Description** · - We are seeking a highly motivated and independent individual for a full-time research assistant position in Dr. Bernardo Sabatini's laboratory at Harvard Medical School. The research assistant will work primarily with Dr. Kimberly Reinhold, a postdoct ...